Collection of Survival and Clinical Data for Multicenter Clinical Trials Using the Qlikview App Provided By CIBMTR 02202019 155 PM Presentation Anderson João Simione Data Analyst Hospital Amaral Carvalho ID: 764278
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Collection of Survival and Clinical Data for Multicenter Clinical Trials Using the Qlikview App Provided By CIBMTR 02/20/2019 1:55 PM
PresentationAnderson João Simione Data AnalystHospital Amaral Carvalho Cinthya Corrêa da Silva Biomedical / Data ManagerHospital Israelita Albert EinsteinThere are no conflicts of interest to disclose
Objective To evaluate Overall Survival (OS) and clinical characteristics of patients undergoing hematopoietic stem cell transplantation (HSCT) in Brazil while testing the usefulness and efficacy of the Qlikview app.
Centers authorized by NTS* to perform BMT in Brazil 87 centers HSCT centers in Brazil Source Data: NST* National Transplant System
Annual number of HSCT in Brazil , N = 3,062 65% (54) Active centers, Year : 2018 Source Data: ABTO State Allogeneic Autologous Total SP 672 840 1,512PR196149345MG105236341PE71137208RJ56145201RS54139193DF4092132CE316091GO102939Brazil1,2351,8273,062
Transplant performed in Brazil - Data from ABTO Years : 2010 - 2018 Source Data: ABTO
Transplant rate per 10 million population Bone Marrow Transplantation . 2017 May;52(5):671-677. doi: 10.1038/bmt.2016.361. Epub 2017 Jan 23.Latin America: the next region for haematopoietic transplant progress Autotransplants Allotransplants
Transplants reported to the CIBMTR, N = 11,518 by country in Latin America, Years: 01/2008 – 01/2019 Country with <50 reported transplants: Chile Source Data : CIBMTR
Source Data: CIBMTR
Scientific Difficulties of Brazilian Centers 1st - Brazil does not have a consolidated database so far; 2st - Difficulty of analysis such as: demographic data, outcomes and scientific production (multicenter study); 3st - Difficulty in developing scientific works;
Curso: Guia de Preenchimento de Dados Essencias Pré e Pós Transplante Multicenter registry of autologous and allogeneic hematopoietic cell transplantations for malignant and non-malignant diseases performed in Brazil at the Center for International Blood and Marrow Transplant Research(CIBMTR)1st Development of a protocol in Brazil in order to formalize the registration of BMT data in the country to the CIBMTR; 2 st Multicentric study;3st Submission to local Ethics Committee in Research;4st Submission to Ethics National Commission in Research;5st 13 centers participating in the project.
Participating Centers in this research Participating HSCT - Brazil TEDCRF Hospital Israelita Albert Einstein x Hospital Amaral Carvalho x Hospital de Clínicas da Universidade Federal do Paraná - HCUFPR x Unicamp x Hospital Universitário Walter Cantídio da Universidade Federal do Ceará / HUWC - UFC x Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer xInstituto Brasileiro de Controle do Câncer - IBCC/ Oncologia Clínica - SP xHospital Samaritano de São Paulo Ltda. xGRAACCx Complexo Hospitalar de Niteróix Universidade Federal de Minas Geraisx Terapia Celular de Natal xHospital das Clínicas - Porto Alegrex
Curso: Guia de Preenchimento de Dados Essencias Pré e Pós Transplante Some Participating Centers in this research
1st Contact the participating centers of the study send the datato the center that is the principal investigator 2st We guide participating centers on how to access and extractthe data in the portalof the CIBMTR - eDBtC,through QlikView 3st We developed the homemade tutorial to assist in extracting data in eDBtC : eDBtC_Tutorial.mp4 4 st We send the video to data manager or professional responsible for processing it by WhatsappStep by Step
Step by Step 5 st step
Indications for the 1st Hematopoietic Cell Transplant in Brazil – (2008-2018)e-DBTc data (7 Brazilian Centers) N=3,994 patients
1st HCT Allogeneic in Brazil (2008-2018)e- DBTc data (7 Brazilian Centers) n=2,448 patients
1st HCT Allogeneic in Brazil (2008-2018)Malignant diseases – Adults (≥18 years)e-DBTc data (7 Brazilian Centers) n=1,258 patients Graft Type
1st HCT Allogeneic in Brazil (2008-2018)Conditioning Regimens in AML, MDSe-DBTc data (7 Brazilian Centers)
Cumulative survival (%) Months 1st HCT Allogeneic in Brazil (2008-2018) – Donor type AML, ALL and MDS – Pediatric (<18 years ) e-DBTc data (7 Brazilian Centers) N = 377 patientsHLA-Matched Related (n=142)OS 61%Unrelated (n=206)OS 57% HLA- Mismatch Related (n=29) OS 60%p = 0.309Overall Survival (OS)
Cumulative survival (%) Months 1st HCT Allogeneic in Brazil (2008-2018) – Donor type AML, ALL and MDS – Adults (≥18 years ) e-DBTc data (7 Brazilian Centers) N = 901 patientsHLA-Matched Related (n=614)OS 54%Unrelated (n=226)OS 45% HLA- Mismatch Related (n=61) OS 40%Overall Survival (OS)p = 0.002
Conclusion The Qlikview it is a useful tool for countries where a national database is not sufficient The Qlikview app allowed the standardized collection and analysis of dataSeveral analysis can be created just with the data downloaded in the e-DBTc
Future Perspectives Data quality improvement Regular analyses the Brazilian data and share with the Brazilian CentersIncrease of the number of the active centers in the CIBMTR
2018 Brazilian meeting - Data Manager
Nelson Hamerschlak , MD, PhD, Medical Coordinator blood and marrow transplantation service - HIAE , President of SBTMOCinthya Corrêa da Silva, Data manager blood and marrow transplantation service - HIAEAnderson João Simioni, Data analyst blood and marrow transplantation service - HACHeliz Regina das Neves, Data analyst/ Data manager blood and marrow transplantation service - UFPR Iracema Esteves , MD, PhD, Hemato and HSCT - HIAE Vergilio Antônio Rensi Colturato vcolturato , Medical Coordinator blood and marrow transplantation service – HACCarmem Maria Sales Bonfim , MD, PhD – Director pediatric blood and marrow transplantation service - UFPR Vaneuza Araújo Moreira Funke Md p, Assistant Professor of Hematology Federal University of Paraná , Head of Adult HSCT Center -Complexo Hospital De Clínicas, Federal University of Parana . Prof. Vaneuza Funke - Hematologia - UFPR Cintia Monteiro – Clinical Nurse Specialist , Data manager – IOP / GRAAC Victor Gottardello Zecchin - MD, MBA, Medical Coodinator Hemato ansd HSCT - IOP/ GRAACCRoberto Luiz da Silva , MD, Medical Coordinator – Hemato and HSCT – IBCCBruna Letícia da Silva Santos Geraldo , Data manager, Nurse coordinator – Hemato and HSCT – Bio Sana’sFernando Barroso Duarte, MD, PhD., Medical Coordinator - Hemato and HSCT – UFCGermison Silva Lopes ,MD, Hemato and HSCT - UFCAfonso Celso Vigorito, MD, PhD, Hemocentro - UNICAMPMarcos Paulo Colella, MD, MSc, Hemocentro -UNICAMP Larissa Codogno Guzelotto, Data Manager, Nurse coordinator - Hemato and HCT – Hemocentro - UNICAMPParticipants Centers